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Showing below up to 50 results in range #51 to #100.

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  1. Document:USA FDA Guidance for Industry - Electronic Source Data in Clinical Investigations Sep-2013 (used on 4 pages)
  2. Template:RegDocument (used on 3 pages)
  3. Template:Reference (used on 3 pages)
  4. Document:EU 2011/C 172/01 - CT-3 11-Jun-2011 (used on 3 pages)
  5. Document:USA U.S. Code Title 21 30-Sep-2023 (used on 3 pages)
  6. Document:USA 21 CFR Part 314 09-Apr-2025 (used on 3 pages)
  7. Document:DEU MBO - Berufsordnung der Ă„rzt:innen 11-Jun-2021 (used on 3 pages)
  8. Document:USA FDA Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs — Improving Human Subject Protection Jan-2009 (used on 3 pages)
  9. Document:FRA AEC DOC012 v03 Avis aux promoteurs d’investigations cliniques de DM (RIPH1) – Partie II 16-May-2025 (used on 3 pages)
  10. Document:EU EMA/786433/2022 Annex V – to guidance for the conduct of good clinical practice inspections – Phase I units 15-Nov-2022 (used on 3 pages)
  11. Document:EU Regulation (EU) 2016/679 (GDPR) 04-May-2016 (used on 3 pages)
  12. Document:GBR UK GDPR - United Kingdom General Data Protection Regulation 31-Dec-2020 (used on 3 pages)
  13. Document:GBR Guidance Access to Electronic Health Records by Sponsor representatives in clinical trials 44447 (used on 2 pages)
  14. Document:FRA DHOS/E1/DAF/DPACI no 2007-322 14-Aug-2007 (used on 2 pages)
  15. Document:INT ISPE - GPP Revision 3 (2015) (used on 2 pages)
  16. Document:EU GUIDANCE ON THE MANAGEMENT OF CLINICAL TRIALS DURING THE COVID-19 (CORONAVIRUS) PANDEMIC v5 10-Feb-2022 (used on 2 pages)
  17. Document:EU COMMISSION IMPLEMENTING DECISION (EU) 2022/729 11-May-2022 (used on 2 pages)
  18. Document:FRA Infographie - La hiérarchie des normes 22-Mar-2024 (used on 2 pages)
  19. Document:CIOMS CIOMS - International Ethical Guidelines for Biomedical Research Involving Human Subjects 2016 (used on 2 pages)
  20. Document:EU Directive 2001/83/EC - Community code relating to medicinal products for human use 20-Jun-12 (used on 2 pages)
  21. Document:EU Regulation (EU) 910/2014 - electronic identification 17-Sep-2014 (used on 2 pages)
  22. Document:GBR IRAS - Integrated Research Application System 28-Jan-2025 (used on 2 pages)
  23. Document:EU Regulation (EU) No 520/2012 - performance of pharmacovigilance activities 20-Jun-12 (used on 2 pages)
  24. Document:USA FDA Guidance for Industry Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects Oct-2009 (used on 2 pages)
  25. Document:GBR Data Protection Act 2018 06-Jun-2022 (used on 2 pages)
  26. Document:GBR Clinical investigations of medical devices – compiling a submission to MHRA May 2021 (used on 2 pages)
  27. Document:CIOMS CIOMS - International Ethical Guidelines for Health-related Research Involving Humans 2016 (used on 2 pages)
  28. Document:ICH ICH E11 Guideline R1 (2017) (used on 2 pages)
  29. Document:USA NIH - SCORE Manual: Appendix Source Documents Requirements Rev 01 16-Aug-2025 (used on 2 pages)
  30. Document:AUT BASG - FAQ 11-Feb-2025 (used on 2 pages)
  31. Document:GBR The Human Medicines Regulations 2012 01-Jan-2025 (used on 1 page)
  32. Document:USA 21 CFR Part 320 09-Apr-2025 (used on 1 page)
  33. Document:USA Expedited Review: Categories of Research that may be Reviewed Through an Expedited Review Procedure 1998 (used on 1 page)
  34. Document:USA NIH - Glossary 27-May-2025 (used on 1 page)
  35. Document:EU ; GBR Regulation (EC) No 1223/2009 - Cosmetic Products 01-Dec-2023 (used on 1 page)
  36. Document:USA 21 CFR Part 809 06-May-2024 (used on 1 page)
  37. Document:EU Regulation (EU) 2017/745 - Medical Device Regulation 05-May-2017 Preamble (used on 1 page)
  38. Document:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 05-May-2017 Preamble (used on 1 page)
  39. Document:USA FDA - E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1): Guidance for Industry March 2018 (used on 1 page)
  40. Document:USA Acceptance of Clinical Data to Support Medical Device Applications and Submissions Frequently Asked Questions - Guidance for Industry and Food and Drug Administration Staff 21-Feb-2018 (used on 1 page)
  41. Document:USA Recognized Consensus Standards - ISO 14155 21-Dec-2020 (used on 1 page)
  42. Document:FRA Guide de légistique 07-Feb-2024 (used on 1 page)
  43. Document:DEU TAMG - Tierarzneimittelgesetz 14-Mar-2024 (used on 1 page)
  44. Document:FRA Code de la Santé Publique - Partie législative - 1ere partie, Livre 1er, Titre II 16-May-2025 (used on 1 page)
  45. Document:EU Regulation (EC) No 726/2004 - authorisation and supervision of medicinal products for human use 28-Jan-22 (used on 1 page)
  46. Document:EU EMA/431265/2016 Annex I – to guidance for the conduct of good clinical practice inspections – investigator site 06-Sep-2017 (used on 1 page)
  47. Document:EU EMA/INS/GCP/143492/2022 - ANNEX I TO PROCEDURE FOR CONDUCTING GCP INSPECTIONS REQUESTED BY THE CHMP: INVESTIGATOR SITE 2022 (used on 1 page)
  48. Document:GBR Medicines and Medical Devices Act 2021 21-Feb-2021 (used on 1 page)
  49. Document:USA FDA INFORMATION SHEET - Recruiting Study Subjects, Guidance for Institutional Review Boards and Clinical Investigators Jan-1998 (used on 1 page)
  50. Document:GBR Guidance - Good clinical practice for clinical trials 16-Oct-2015 (used on 1 page)

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